Method and apparatus for monitoring and controlling peritoneal dialysis therapy

ABSTRACT

A peritoneal dialysis system includes: (i) a fluid cassette including diaphragm operated first and second pump chambers; (ii) a first pressure sensor operable with the first pump chamber; (iii) a second pressure sensor operable with the second pump chamber; and (iv) a to-patient port of the cassette in fluid communication with the first and second pump chambers, wherein the first pressure sensor is located between the first pump chamber and the to-patient port and the second pressure sensor is located between the second pump chamber and the to-patient port.

PRIORITY CLAIM

This application is a continuation of U.S. patent application Ser. No.10/446,068, filed May 27, 2003, entitled “Method And Apparatus ForMonitoring And Controlling Peritoneal Dialysis Therapy,” Attorney DocketNo. DI-5429 CN2, which is a divisional application of U.S. patentapplication Ser. No. 10/078,568, filed Feb. 14, 2002, having the sametitle as above, issued as U.S. Pat. No. 6,592,542, which is acontinuation of U.S. patent application Ser. No. 09/501,778, filed Feb.10, 2000, having the same title as above, issued as U.S. Pat. No.6,497,676. Both disclosures are hereby incorporated by reference herein.

BACKGROUND

The present invention relates generally to the treatment of end stagerenal disease. More specifically, the present invention relates tomethods and apparatus for monitoring the performance of peritonealdialysis.

Using dialysis to support a patient whose renal function has decreasedto the point where the kidneys no longer sufficiently function is known.Two principal dialysis methods are utilized: hemodialysis; andperitoneal dialysis.

In hemodialysis, the patient's blood is passed through an artificialkidney dialysis machine. A membrane in the machine acts as an artificialkidney for cleansing the blood. Because it is an extracorporealtreatment that requires special machinery, certain inherentdisadvantages exist with hemodialysis.

To overcome the disadvantages associated with hemodialysis, peritonealdialysis was developed. Peritoneal dialysis utilizes the patient's ownperitoneum as a semi-permeable membrane. The peritoneum is a membranouslining of the abdominal body cavity. Due to good perfusion; theperitoneum is capable of acting as a natural semi-permeable membrane.

Peritoneal dialysis periodically infuses sterile aqueous solution intothe peritoneal cavity. This solution is called peritoneal dialysissolution, or dialysate. Diffusion and osmosis exchanges take placebetween the solution and the blood stream across the natural bodymembranes. These exchanges remove the waste products that the kidneysnormally excrete. The waste products typically consist of solutes likeurea and creatinine. The kidneys also maintain the levels of othersubstances such as sodium and water which need to be regulated bydialysis. The diffusion of water and solutes across the peritonealmembrane during dialysis is called ultrafiltration.

In continuous ambulatory peritoneal dialysis, a dialysis solution isintroduced into the peritoneal cavity utilizing a catheter. An exchangeof solutes between the dialysate and the blood is achieved by diffusion.Further removal is achieved by providing a suitable osmotic gradientfrom the blood to the dialysate to permit water outflow from the blood.This allows a proper acid-base, electrolyte and fluid balance to beachieved in the body. The dialysis solution is simply drained from thebody cavity through the catheter.

Peritoneal dialysis raises a number of concerns including: the danger ofperitonitis; a lower efficiency and therefore increased duration ofdialysis hours compared to hemodialysis; and costs incurred whenautomated equipment is utilized.

A number of variations on peritoneal dialysis have been explored. Onesuch variation is automated peritoneal dialysis (“APD”). APD uses amachine, called a cycler, to automatically infuse, dwell, and drainperitoneal dialysis solution to and from the patient's peritonealcavity. APD is particularly attractive to a peritoneal dialysis patient,because it can be performed at night while the patient is asleep. Thisfrees the patient from the day-to-day demands of continuous ambulatoryperitoneal dialysis during his/her waking and working hours.

The APD sequence typically lasts for several hours. It often begins withan initial drain cycle to empty the peritoneal cavity of spentdialysate. The APD sequence then proceeds through a succession of fill,dwell, and drain phases that follow one after the other. Eachfill/dwell/drain sequence is called a cycle. APD can be and is practicedin a number of different ways.

Current APD systems do not monitor the patient intraperitoneal pressureduring a therapy session. Current systems simply limit the externalpressure (or suction) that a pump can apply to the line or lumen that isattached to the patient catheter. If the patient is located below thesystem, sometimes referred to as a cycler, a gravity head will add tothe positive fill pressure that the cycler can apply to the patientcatheter. Conversely, if the patient is located above the cycler, thegravity head will decrease from the positive fill pressure that thecycler can apply to the patient catheter.

The monitoring of intraperitoneal pressure would be useful becausecyclers will sometimes not fully drain a patient between cycles.Specifically, currently-available cyclers are unable to determinewhether a patient absorbed some fluid or whether some fluid is simplynot able to be drained out because of the position of the patient or thecatheter.

As a result, some currently-available systems utilize a minimum drainthreshold to determine the amount of fluid that should be delivered tothe patient during the next fill. For example, if 85% of the fill volumehas been drained when the cycler determines that the patient is “empty”,the next fill volume will be 100%. If only 80% were drained, the nextfill volume would be limited to 95%.

A negative ultrafiltrate (uF) alarm will sound when the patient hasretained more than a predetermined percentage of the fill volume. Thepredetermined percentage can typically be either 50% or 100% of the fillvolume. However, the patient can override this alarm if he/she does notfeel overfull. The number of times the patients can override the uFalarm during a single therapy may be limited by the software of thecycler. However, the uF alarm typically does not consider the actualultrafiltrate that may also accumulate in the peritoneal cavity alongwith the dialysate.

Currently-available cyclers fill the patient to a specific,preprogrammed volume during each cycle. The doctor prescribes this fillvolume based upon the patient's size, weight and other factors. However,because currently-available cyclers cannot monitor intraperitonealpressure, the doctor cannot take this factor into account whenformulating the prescription. It is also known that intraperitonealpressure (IPP) has an effect on ultrafiltration (UF).

FIGS. 1-3 provide schematic illustrations of current APD cyclers. Noneof them attempt to monitor intraperitoneal pressure.

Referring to FIG. 1, a cycler 10 a is illustrated which includes adialysate container 11, a patient 12 and a drain container 13 areillustrated schematically. The infusion of dialysate from the container11 into the patient 12 is caused by the gravitational head indicated at14 while the draining of used dialysate from the patient 12 to the draincontainer 13 is caused by the drain head indicated at 15. The cycler 10a includes no sensors for monitoring the pressure inside the peritoneumof the patient 12. A single lumen 16 connects both the dialysatecontainer 11 and drain container 13 to the patient 12. Valves 17, 18operated by the cycler 10 a control the flow of either dialysate fromthe container 11 to the patient 12 or waste material from the patient 12to the drain container 13.

Turning to FIG. 2, in the cycler 10 b, the drain container 13 anddialysate container 11 are contained within a pressurized chamber 19.The chamber 19 can be pressurized or evacuated to either fill or drainthe patient. Again, the selective operation of valves 17, 18 controlwhether dialysate is being transferred to or from the patient 12. Again,no sensors are provided for detecting or monitoring intraperitonealpressure of the patient 12.

Turning to FIG. 3, in the system 10 c, a dialysate container 11 isconnected to a pump 21 which, in turn, connects the dialysate container11 to a common lumen or catheter 16 which is connected to the patient. Afluid flow control valve is provided at 23 and is controlled by thecycler 10 c. The drain container 13 is also connected to a pump 24which, in turn, connects the drain container 13 to the lumen 16. Acontrol valve is again provided at 25.

The drain and fill rates of the cyclers 10 a-10 c illustrated in FIGS.1-3 are determined by the gravitational head (see FIG. 1) or the suctionor pressure (see FIGS. 2 and 3) applied to the patient line 16.Typically, the cyclers 10 a-10 c fail to optimize either the fill rateor the drain rate because the pressure is either fixed by thegravitational head or the pressure or suction applied by the chamber 10b of FIG. 2 which occurs at the opposing end of the patient line 16.Thus, without measuring the intraperitoneal pressure or having a way toestimate the same, it is difficult to optimize either the drain or fillrate. In the case of the cycler 10 c in FIG. 3, optimizing the drain orfill rate is guesswork due to the lack of any pressure reading at all.

Accordingly, there is a need for an improved cycler that measurespatient intraperitoneal pressure during a therapy session, includingboth during the drain and the fill as well as the dwell. Further, thereis a need for an improved cycler that measures intraperitoneal pressureand which would use that data to more completely drain a patient betweencycles. Further, there is a need for an improved cycler which wouldaccurately measure intraperitoneal pressure to avoid overfilling apatient. Finally, there is a need for an improved cycler which wouldmonitor intraperitoneal pressure during both the fill and drain cyclesto optimize the speed at which the patient is filled and drained and totherefore increase the dwell portion of a therapy session.

SUMMARY

The present invention satisfies the aforenoted needs by providing asystem for providing peritoneal dialysis to a patient which comprises adialysate container connected to the patient with a first pressuresensor connected in-line herebetween, and a drain container connected tothe patient with a second pressure sensor connected in-linetherebetween.

In an embodiment, the system further comprises a first pump disposedin-line between the dialysate container and the first pressure sensor.

In an embodiment, the dialysate flows from the dialysate container intothe patient under a hydrostatic head.

In an embodiment, a second pump is disposed in-line between the draincontainer and the second pressure sensor.

In an embodiment, the dialysate flows from the patient to the draincontainer under a hydrostatic head.

In an embodiment, the second pressure sensor measures an intraperitonealpressure of the patient while dialysate flows from the dialysatecontainer to the patient.

In an embodiment, the first pressure sensor measures an intraperitonealpressure of the patient while dialysate flows from the patient to thedrain container.

In an embodiment, the system further comprises a first lumen connectingthe dialysate container to the first sensor and the first sensor to acatheter, and a second lumen connecting the drain container to thesecond sensor and the second sensor to the catheter, the catheter beingconnected to the patient, a flow of dialysate from the patient to thedrain container evacuating dialysate from the first lumen and causingsaid dialysate from the first lumen to flow through the second lumen andto the drain container.

In an embodiment, the catheter is a dual lumen catheter.

In an embodiment, the first and second sensors are redundant in-linepressure/vacuum sensors.

In an embodiment, the present invention provides a method for dialyzinga patient comprising the steps of: placing a catheter in a peritoneum ofthe patient; providing at least one dialysate container; connecting thedialysate container to the catheter with a first lumen that includes afirst pressure sensor disposed in-line and between the catheter and thedialysate container; providing at least one drain container; connectingthe drain container to the catheter with a second lumen that includes asecond pressure sensor disposed in-line and between the catheter and thedrain container; transferring dialysate from the dialysate container tothe peritoneum of the patient and monitoring an intraperitoneal pressureof the patient with the second pressure sensor; and transferringdialysate from the peritoneum of the patient to the drain container andmonitoring the intraperitoneal pressure of the patient with the firstpressure sensor.

In an embodiment, the step of transferring dialysate from the dialysatecontainer to the peritoneum of the patient further comprises pumpingdialysate from the dialysate container to the patient with a first pumpdisposed in-line between the dialysate container and the first pressuresensor.

In an embodiment, the step of transferring dialysate from the peritoneumof the patient to the drain container further comprises pumpingdialysate from the peritoneum of the patient to the drain container witha second pump disposed in-line between the drain container and thesecond pressure sensor.

In an embodiment, the dialysate container is disposed vertically abovethe peritoneum of the patient and the step of transferring dialysatefrom the dialysate container to the peritoneum of the patient furthercomprises flowing dialysate from the dialysate container to the patientunder a hydrostatic head.

In an embodiment, the drain container is disposed vertically below theperitoneum of the patient and the step of transferring dialysate fromthe peritoneum of the patient to the drain container further comprisesflowing dialysate from the peritoneum of the patient to the draincontainer under a hydrostatic head.

Other objects and advantages of the invention will become apparent uponreading the following detailed description and appended claims, and uponreference to the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates, schematically, a prior art automated peritonealdialysis system;

FIG. 2 illustrates, schematically, a prior art automated peritonealdialysis system;

FIG. 3 illustrates, schematically, a prior art automated peritonealdialysis system;

FIG. 4 illustrates, schematically, an automated peritoneal dialysissystem made in accordance with the present invention;

FIG. 5 illustrates, schematically, a second embodiment of an automatedperitoneal dialysis system made in accordance with the presentinvention;

FIG. 6 illustrates, schematically, a third embodiment of an automatedperitoneal dialysis system made in accordance with the presentinvention;

FIG. 7 illustrates, schematically, a fourth embodiment of an automatedperitoneal dialysis system made in accordance with the presentinvention;

FIG. 8 illustrates a pressure sensor made in accordance with the presentinvention;

FIG. 9 illustrates a fifth embodiment incorporating dual pumpingchambers and pressure sensors made in accordance with the presentinvention;

FIG. 10 illustrates, schematically, a dual lumen catheter that can beutilized with the present invention;

FIG. 11 is a sectional view taken substantially along line 11-11 of FIG.10; FIG. 12 illustrates, graphically, the urea concentration in bloodand the urea concentration in a dialysate during a multiple dwelldialysis session;

FIG. 13 illustrates, graphically, the concentration of urea in apatient's bloodstream versus the concentration of urea in a dialysatesolution for an automated peritoneal dialysis solution practiced inaccordance with the prior art; and

FIG. 14 illustrates, graphically, the concentration of urea in apatient's bloodstream versus the concentration of urea in a dialysatefor an automated peritoneal dialysis therapy session carried out inaccordance with the present invention.

It should be understood that the drawings are not necessarily to scaleand that the embodiments are sometimes illustrated by graphic symbols,phantom lines, diagrammatic representations and fragmentary views. Incertain instances, details which are not necessary for an understandingof the present invention or which render other details difficult toperceive may have been omitted. It should be understood, of course, thatthe invention is not necessarily limited to the particular embodimentsillustrated herein.

DETAILED DESCRIPTION

Turning to FIG. 4, a cycler 30 includes a dialysate container 11connected to a pump 31. The pump 31 is connected to a pressure sensor32. The pump 31 and pressure sensor 32 are disposed in-line in a lumen33 that connects the dialysate container 11 to a catheter 34. Controlvalves are provided at 35, 36. A drain container 13 is also connected toa pump 36 which is connected to a sensor 37. The pump 36 and sensor 37are also connected in-line to a lumen 38 which connects the draincontainer 13 to the catheter 34. Control valves are again provided at41, 42. During the fill, the pump 31 pumps dialysate from the container11 through the lumen 33 and catheter 34 into the peritoneum (not shown)of the patient 12. During this time, the sensor 37 monitors and measuresthe intraperitoneal pressure. A signal is sent to the controller of thecycler 30 shown schematically at 43. A control panel is indicatedgenerally at 44.

During the drain, the sensor 31 can accurately monitor and measure theintraperitoneal pressure of the patient 12. In the embodimentillustrated in FIG. 4, no pumps or control valves are disposed betweenthe sensor 32 and the patient 12.

Turning to FIG. 5, a cycler 50 is illustrated which includes reversiblepumping chambers 51, 52 with sensors 53, 54 disposed between thereversible pumping chambers 51, 52 and the patient 12 respectively.Control valves 55 and 56 are disposed on another side of the reversiblepumping chamber 51 and the sensor 53 and control valves 57, 58 areprovided on either side of the reversible pumping chamber 52 and sensor54. The sensors 53, 54 actually measure the pressure on the diaphragmsof the reversible pumping chambers 51, 52.

Turning to FIG. 6, a cycler 60 is illustrated with a chamber 61 foraccommodating the drain container 13 and a chamber 62 for accommodatingthe dialysate container 11. Each chamber 61, 62 is equipped with anintegrated valve assembly and pressure sensor shown at 63, 64. In theembodiment 60 shown in FIG. 6, the chamber 61 must be capable of beingevacuated. Dialysate may flow from the dialysate container 11 by way ofgravity or pressure fill. Again, the sensors of the valveassembly/sensor combinations 63, 64 monitor the intraperitoneal pressureof the patient 12 as discussed above.

In the embodiment 70 illustrated in FIG. 7, the dialysate container 11and drain container 13 are both connected to integrated control valvesand pressure sensors 71, 72. Each of the integrated control valves andpressure sensors 71, 72 are connected to lumens 73, 74 respectivelywhich are connected to the catheter 75 a by way of a Y-connection. Thedetails of all the Y-connections and clamps are not shown but are knownto those skilled in the art. Flow from the dialysate container 11 to thepatient is carried out under the gravitational head shown at 75 whileflow from the patient to the drain container 13 is carried out under thegravitational head shown at 76.

FIG. 8 illustrates one in-line pressure sensor 80 that is suitable foruse with the present invention. Redundant load cells 81, 82 areconnected to the flexible pressure sensing membrane 83 by a vacuumconnected by the line 84, 85. A lumen connecting the cycler to thepatient is shown at 86.

FIG. 9 illustrates a dual-pumping chamber cassette 87 which includes anoutput line 88 which connects the cassette 87 to the patient and aninput line 89 connecting the patient to the cassette 87. The line 90connects the cassette 87 to the dialysate container (not shown). Eachpumping chamber 91, 92 are in communication with all three lines 88, 89and 90. Thus, every line can be connected to either pumping chamber 91,92. The pumping chambers 91, 92 are bound on one side by a commondiaphragm shown at 93. Flow is controlled by the use of diaphragm valvesshown at 94, 95, 96 and 97. Pressure sensors are shown at 120, 121, 122,123, 124, 125. However, pressure sensors 123 and 120 are the sensorsused to measure intraperitoneal pressure in accordance with the presentinvention. The remaining sensors 121, 122, 124, 125 are used to monitorthe operation of the pumps 126, 127.

When the left diaphragm pump 126 is pushing dialysate to the patient,the sensor 123 can measure the intraperitoneal pressure through the line89. When the left diaphragm pump 126 is draining fluid from the patientthrough the line 89, the sensor 120 can measure intraperitoneal pressurethrough the line 88 and while the right pump 127 is pumping fluid to thedrain container (not shown) through the drain line shown schematicallyat 128. When the right diaphragm pump 127 is being used to drain fluidfrom the patient, the sensor 120 can measure intraperitoneal pressurewhile the left diaphragm pump 126 is pumping fluid to the draincontainer (not shown) through the drain line shown schematically at 129.

FIGS. 10 and 11 illustrate a dual-lumen catheter 100 which includesseparate passageways 101, 102. The employment of a dual lumen catheter100 as compared to a dual lumen patient line can move the point at whichthe pressure is measured to within the peritoneum itself by way ofcommunication through the separate flowpaths 101, 102. The dual lumencatheter 100 installs like a single lumen catheter, yet will functioneither as a flow through or a standard catheter. Both fluid pathways101, 102 are used to withdraw and deliver fluid during the drain andfill. While one pathway delivers fluid, the other pathway drains. Theend section, shown generally at 103, is perforated.

A comparison of an APD therapy for a prior art APD cyclers and onemanufactured in accordance with the present invention are summarized asfollows: Therapy Parameter Current APD Cycler Cycler Using InventionTotal Therapy Volume 15 liters 15 liters Fill Volume 2.2 liters 2.5liters max Fill Pressure Limit not applicable 14 mm Hg max Total TherapyTime 8 hours 8 hours Last (Day) Fill Volume 1,500 ml 1,500 ml Last FillDextrose Same Same Initial Drain Alarm 1,200 ml 1,200 ml Drain X of NAlarm 80% 80%

TABLE 1 Comparison of Therapies for Current Cyders versus Cycler usingInvention Method Therapy Phase Therapy Parameter Prior Art Cycler 1Prior Art Cycler 2 Invention Cycler 3 Initial Drain Drain Volume 1,200ml 1,200 ml 1,200 ml Patient Volume 300 ml 300 ml 300 ml Fill I of 5Fill Volume 2,200 ml 2,200 ml 2,500 ml Patient Volume 2,500 2,500 2,800Fill Pressure not applicable not applicable 12 mm Hg Drain 1 of 5 DrainVolume 1,800 ml 2,200 ml 2,200 ml Patient Volume 700 ml 300 ml 600 mlFill 2 of 5 Fill Volume 2,200 ml 2,200 ml 2,400 ml Patient Volume 2,900ml 2,500 ml 3,000 ml Patient Pressure not applicable not applicable 14mm Hg Drain 2 of 5 Drain Volume 1,800 ml 2,200 ml 2,200 ml PatientVolume 1,100 ml 300 ml 800 ml Fill 3 of 5 Fill Volume 2,200 ml 2,200 ml2,200 ml Patient Volume 3,300 ml 2,500 ml 3,000 ml Patient Pressure notapplicable not applicable 14 mm Hg Drain 3 of 5 Drain Volume 1,801 ml2,200 ml 2,200 ml Patient Volume 1,499 ml 300 ml 800 ml Fill 4 of 5 FillVolume 2,200 ml 2,200 ml 2,200 ml Patient Volume 3,699 ml 2,500 3.000 mlPatient Pressure not applicable not applicable 3,000 ml Drain 4 of 5 IDrain Volume 1,800 ml 2,200 ml 2,200 ml Patient Volume 1,899 ml 300 ml800 ml Fill 5 of 5 Fill Volume uF Alarm Bypass 2,200 ml 2,200 ml 2,200ml Patient Volume 4,099 ml 2,500 ml 3,00 ml Patient Pressure PatientWakes not 14 mm Hg Overfull, applicable Manually Drains 1,500 ml Drain 5of 5 Drain Volume 1,800 ml 2,200 ml 2,200 ml Patient Volume 799 ml 300ml 800 ml Final Fill Fill Volume 1,500 ml 1,500 ml 1,500 ml

Inspection of Table 1 shows that cycler 1 woke the patient at around4:30 in the morning with a negative uF alarm at the beginning of Fill 5.The patient bypassed the alarm because he did not feel overfull andimmediately fell back asleep. He woke up about minutes later when he haddifficulty breathing and felt extremely overfull. He manually drainedabout 1500 ml but was unable to go back to sleep. He filed a formalproduct complaint with the manufacturer.

The data of Table I shows that cycler 2 ran a completely normal therapybut the total therapy clearance (calculated based upon the sum of thenight patient volumes) was only 84.5% of that obtained by cycler 3,which was using the cycler that used the method of the currentinvention.

The data of Table 1 shows that cycler 3 ran a completely normal therapyand that the fill volume was limited on one occasion by the maximum fillvolume but on four occasions by the patient's intraperitoneal pressure.This patient never felt any discomfort and had no alarms during thenight. The limit on the IPP prevented him from being overfilled eventhough he had successive drains that were not complete. The volume offluid in his peritoneum never exceeded 3 liters.

The patient on cycler 1 had an intraperitoneal pressure in excess of 14mm Hg during dwells 3 and 4. His breathing may have been impaired andhis heart may have had to work harder but the discomfort was not enoughto wake him up from a sound sleep until it peaked at 4,099 ml duringdwell 5.

In conclusion, the method of the present invention provides for optimumfills and therefore more clearance while preventing overfills that bringdiscomfort and inhibit the function of vital body organs. A negative uFalarm would seldom occur because overfills of the required magnitudewould be prevented by the IPP sensors.

Calculation of Intraperitoneal Pressure (IPP)

In order to calculate the IPP, one may first calculate the patient headheight correction using conservation of energy:Δ(½ρV ² +P−pa _(g) h)+Frictional Losses=0

The velocity V of fluid through the patient line is the same at bothends of the line as is the fluid density, so this equation can bewritten as(P ₂ −P ₁)−pa _(g)(h ₂ h,)+Frictional Losses=0

which can be rearranged as${\Delta\quad h} = \frac{\left( {P_{1} - P_{2}} \right) - {{Frictional}\quad{Losses}}}{\rho\quad a_{g}}$

EXAMPLE 1

P1=1.25 psig=85060 (gram/cm)/(cm²-sec²)

P2=0.9 psig=61240 (gram/cm)/(cm²-sec²)

Frictional Losses=39130 (gram/cm)/(cm²-sec²) with flow of 197 cm/min ina 4 mm ID line at a velocity of approximately 172 cm/sec, wherein

a_(g)=981 cm/sec²

ρ=1 gram/cm³${\Delta\quad h} = \frac{\left( {\left( {85060 - 61240} \right) - 39130} \right)\quad{\left( {{gram}/{cm}} \right)/\left( {{cm}^{2} - \sec^{2}} \right)}}{1\quad{{gram}/{cm}}*981\quad{{cm}/\sec^{2}}}$

Δh=−15.6 cm (The patient is 15.6 cm below the membrane)

EXAMPLE 2

PI=1.25 psig=85060 (gram/cm)/(cm²-sec²) P2=0.45 psig=30620(gram/cm)/(cm²-sec²)

Frictional Losses=39130 (gram/cm)/(cm²-sec²) with flow of 197 cmn/min ina 4 mm ID line at a velocity of approximately 172 cm/sec, wherein

a_(g)=981 cm/sec²

ρ=1 gram/cm³${\Delta\quad h} = \frac{\left( {\left( {85060 - 30620} \right) - 39130} \right)\quad{\left( {{gram}/{cm}} \right)/\left( {{cm}^{2} - \sec^{2}} \right)}}{1\quad{{gram}/{cm}^{3}}*981\quad{{cm}/\sec^{2}}}$

Δh=+15.6 cm (The patient is 15.6 cm above the membrane)

The patient head height can be established at the beginning of eachfill. Any changes in the head height that occur during the fill can beattributed to an increase in intraperitoneal pressure (IPP) since thepatient is asleep.

Turning to FIG. 12, the concentration gradient between the ureaconcentration 110 in the patient's blood and the urea concentration 111in the dialysate for typical APD cyclers is illustrated graphically.Comparing the results illustrated in FIGS. 13 and 14, it is evident thatAPD cyclers equipped with the sensors of the present invention providesuperior results. Specifically, the data illustrated graphically in FIG.13 was obtained using a prior art APD cycler. The data obtained in FIG.14 was obtained using an APD cycler utilizing two sensors for monitoringintraperitoneal pressure. Note that the urea concentration 110 in thebloodstream is lower in FIG. 14 than in FIG. 13. Further note, thedialysate volume or fill volume is lower for the therapy illustrated inFIG. 14 than the therapy illustrated in FIG. 13. Thus, the presentinvention provides improved urea clearance with lower fill volumes.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications may be madewithout departing from the spirit and scope of the present invention andwithout diminishing its attendant advantages. It is, therefore, intendedthat such changes and modifications be covered by the appended claims.

1. A peritoneal dialysis system comprising: a first pump actuator; asecond pump actuator; first and second diaphragm pump chambers operablewith the first and second pump actuators, respectively; a pressuresensor located between the first diaphragm pump chamber and a fluidvalve; and a patient line in fluid communication with the fluid valve;and wherein the system is configured to receive a signal from thepressure sensor and use the signal to modify a peritoneal dialysistreatment performed by the system.
 2. The peritoneal dialysis system ofclaim 1, wherein the pressure sensor is positioned to sense a pressureexerted on the diaphragm of the first pump chamber.
 3. The peritonealdialysis system of claim 1, the pressure sensor and fluid valve a firstsensor and a first fluid valve, respectively, and which includes asecond pressure sensor located between a second fluid valve and thesecond pump chamber.
 4. The peritoneal dialysis system of claim 3,wherein the second pressure sensor is positioned to sense a pressure onthe diaphragm of the second pump chamber.
 5. The peritoneal dialysissystem of claim 3, the patient line being a patient outlet line, andwhich includes a patient inlet line in fluid communication with thesecond fluid valve.
 6. The peritoneal dialysis system of claim 1, thefluid valve a first fluid valve, and which includes at least oneadditional fluid valve placed between at least one of: (i) the firstpump chamber and a dialysate source and (ii) the second pump chamber anda dialysate drain.
 7. A peritoneal dialysis system comprising: a firstdiaphragm operated pump chamber; a second diaphragm operated pumpchamber; a first pressure sensor positioned to sense a fluid pressureexerted on the diaphragm of the first pump chamber; a second pressuresensor positioned to sense a fluid pressure exerted on the diaphragm ofthe second pump chamber; and wherein the system is configured to receivea signal from at least one of the pressure sensors and use the at leastone signal to modify a peritoneal dialysis treatment performed by thesystem.
 8. The peritoneal dialysis system of claim 7, wherein the firstand second pump chambers are configured for two-way pumping.
 9. Theperitoneal dialysis system of claim 7, wherein the fluid pressureexerted on one of the diaphragms and sensed by one of the sensors is afrom-patient fluid pressure and the fluid pressure exerted on the otherdiaphragm and sensed by the other pressure sensor is a to-patient fluidpressure.
 10. The peritoneal dialysis system of claim 7, wherein thefirst and second diaphragm operated pump chambers are part of a fluidcassette.
 11. A peritoneal dialysis system comprising: a fluid cassetteincluding a diaphragm operated pump chamber; a pressure sensor operatingwith the diaphragm, wherein fluid pumped via the pump chamber flowsalong the diaphragm at the pressure sensor; and wherein the system isconfigured to receive a signal from the pressure sensor and use thesignal to ensure that a pressure of the fluid inside a patient (“IPP”)does not exceed a pressure limit.
 12. The peritoneal dialysis system ofclaim 11, which is configured to limit a fill volume to the patientbased on the pressure limit.
 13. The peritoneal dialysis system of claim11, which is configured to allow the pump chamber to pump fluid to thepatient until the IPP reaches the pressure limit.
 14. The peritonealdialysis system of claim 11, which is configured to relate IPP to a headheight of the patient.
 15. The peritoneal dialysis system of claim 11,which is configured to calculate a head height of the patient based onmultiple signals from the pressure sensor.
 16. A peritoneal dialysissystem comprising: a fluid cassette including diaphragm operated firstand second pump chambers; a first pressure sensor operable with thefirst pump chamber; a second pressure sensor operable with the secondpump chamber; and a to-patient port of the cassette in fluidcommunication with the first and second pump chambers, wherein the firstpressure sensor is located between the first pump chamber and theto-patient port and the second pressure sensor is located between thesecond pump chamber and the to-patient port.
 17. The peritoneal dialysissystem of claim 16, wherein the cassette includes a dialysate inlet portin fluid communication with the first and second pump chambers, thefirst and second pressure sensors located downstream from the dialysateinlet port.
 18. The peritoneal dialysis system of claim 16, whichincludes a plurality of valves located between the first and second pumpchambers, one of the pressure sensors located between the plurality ofvalues.
 19. The peritoneal dialysis system of claim 18, wherein theplurality of valves each operate with the diaphragm of the cassette. 20.The peritoneal dialysis system of claim 16, wherein the first and secondpressure sensors operate with the diaphragm of the cassette.